A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data.
The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.
Gidudu
Jane
J
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. secretariat@brightoncollaboration.org
Kohl
Katrin S
KS
Halperin
Scott
S
Hammer
Sandra Jo
SJ
Heath
Paul T
PT
Hennig
Renald
R
Hoet
Bernard
B
Rothstein
Edward
E
Schuind
Anne
A
Varricchio
Frederick
F
Walop
Wikke
W
D003625:Data Collection; D003627:Data Interpretation, Statistical; D003710:Demography; D004282:Documentation; D005568:Forms and Records Control; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007267:Injections / Q000009:adverse effects*; D012449:Safety; D012867:Skin / Q000473:pathology*; D009626:Terminology as Topic; D014611:Vaccination / Q000009:adverse effects*